The detection of the level of glucose or other analytes, such as lactate, oxygen or the like, in certain individuals is vitally important to their health. For example, the monitoring of glucose is particularly important to individuals with diabetes. Diabetics may need to monitor glucose levels to determine when insulin is needed to reduce glucose levels in their bodies or when additional glucose is needed to raise the level of glucose in their bodies.
Devices have been developed for continuous or automatic monitoring of analytes, such as glucose, in bodily fluid such as in the blood stream or in interstitial fluid. Some of these analyte measuring devices are configured so that at least a portion of the devices are positioned below a skin surface of a user, e.g., in a blood vessel, in the subcutaneous or dermal tissue of a user.
It is important for devices that are to be implanted in the body or positioned below a skin surface of a user, such as in a blood vessel or subcutaneous tissue, to be sterile upon insertion into the user. Sterilization is any number of processes that effectively eliminate or kill transmissible agents, such as bacteria, fungi, and viruses, that may be located on a non-sterile device. These transmittable agents, if not eliminated from the device, may be substantially detrimental to the health and safety of the user.
Existing techniques for sterilization of medical devices, kits or components generally meet several challenges. Whether the sterilization includes the use of chemicals or irradiation of light beams, in order to attain the desired sterility assurance level (SAL), there are considerations that must be accounted for. For example, when a target device or component for sterilization includes different materials having different properties such as metal, plastic, biologics, chemistries, including any combination thereof, the challenges of sterilization can be significant. In addition, when a target device or component is already packaged prior to sterilization, the material comprising the packaging as well as its properties, such as porosity, needs to be considered, further increasing the sterilization challenges.